Celsion Affirms July Timing for Second Interim Analysis of the Phase III OPTIMA Study of ThermoDox® in Primary Liver Cancer
June 25 2020 - 8:00AM
Celsion Corporation (NASDAQ:
CLSN), an oncology drug-development company, today
affirmed that the independent Data Monitoring Committee (iDMC) is
scheduled to meet during the first half of July to conduct the
second pre-planned interim safety and efficacy analysis of the
Phase III OPTIMA Study with ThermoDox® plus RFA (radiofrequency
ablation) in patients with hepatocellular carcinoma (HCC), or
primary liver cancer. Members of the iDMC represent the global
market for HCC and are based in the U.S., Canada and Europe, and
Celsion believes that any logistical challenges to the Committee’s
performing its work presented by the global COVID-19 pandemic have
been addressed. Celsion expects to announce the iDMC’s
recommendations and Company next steps soon after the meeting
concludes.
Data lock for the second pre-specified interim
analysis occurred during April 2020 after the prescribed minimum
number of events of 158 patient deaths was reached.
As previously announced, the hazard ratio for
success at 158 deaths is 0.70, which represents a 30% reduction in
the risk of death compared with RFA alone. The p-Value required is
0.022. Both compare favorably with the hazard ratio of 0.65 and
p-Value = 0.02 observed in the prospective HEAT Study subgroup upon
which the OPTIMA Study is based.
Michael H. Tardugno, Celsion’s chairman,
president and chief executive officer, said, “The iDMC meeting is
expected to take place as planned and we look forward to receiving
their recommendation. While we are hopeful for a positive outcome,
it is not a binary event for the OPTIMA Study. Should the data not
reach the threshold for success, we believe the OPTIMA Study is
ultimately well-positioned for success at the final analysis, if
necessary. The final analysis would be based on 197 patient deaths
where the hazard ratio for success is 0.75 or a 25% reduction in
the risk of death, with a p-Value = 0.042. We believe that a
successful study has blockbuster revenue potential and, more
importantly, will be globally transformational for patients with
HCC, the largest unmet need in oncology with more than 750,000
cases annually.”
About the OPTIMA Study
The Phase III OPTIMA Study enrolled 556 patients
at 65 clinical sites in North America, Europe, China and Asia
Pacific. The Study is evaluating ThermoDox® in combination with
optimized RFA, which will be standardized to a minimum of 45
minutes across all investigators and clinical sites for treating
lesions 3-7 cm in size, versus optimized RFA alone. The primary
endpoint for the trial is Overall Survival, which is supported by
post-hoc analyses of data from the Company's 701-patient HEAT
Study, where optimized RFA demonstrated the potential to
significantly improve survival when combined with ThermoDox®. The
statistical plan calls for two interim efficacy analyses by an
independent Data Monitoring Committee.
About ThermoDox®
Celsion’s most advanced program is a
heat-mediated drug delivery technology that employs a novel
heat-sensitive liposome engineered to address a range of
difficult-to-treat cancers. The first application of this platform
is ThermoDox®, a lyso-thermosensitive liposomal doxorubicin (LTLD)
whose novel mechanism of action delivers high concentrations of
doxorubicin to a region targeted with the application of localized
heat at 40°C, just above body temperature. ThermoDox® is positioned
for use with multiple heating technologies and has the potential to
treat of a broad range of cancers including metastatic liver,
recurrent chest wall breast cancer and non-muscle invading bladder
cancers.
Celsion’s LTLD technology leverages two
mechanisms of tumor biology to deliver higher concentrations of
drug directly to the tumor site. In the first mechanism, rapidly
growing tumors have leaky vasculature, which is permeable to
liposomes and enables their accumulation within tumors. Leaky
vasculature influences a number of factors within the tumor,
including the access of therapeutic agents to tumor cells.
Administered intravenously, ThermoDox® is engineered with a
half-life to allow significant accumulation of liposomes at the
tumor site as these liposomes recirculate in the blood stream.
In the second mechanism, when an external
heating device heats tumor tissue to a temperature of 40°C or
greater, the heat-sensitive liposome rapidly changes structure and
the liposomal membrane selectively dissolves, creating openings
that can release a chemotherapeutic agent directly into the tumor
and the surrounding vasculature. Drug concentration increases as a
function of the accumulation of liposomes at the tumor site, but
only where the heat is present. This method damages only the tumor
and the area subject to tumor invasion, supporting more precise
drug targeting.
About Celsion
Corporation
Celsion is a fully integrated oncology company
focused on developing a portfolio of innovative cancer treatments,
including directed chemotherapies, immunotherapies and RNA- or
DNA-based therapies. The Company’s lead program is ThermoDox®, a
proprietary heat-activated liposomal encapsulation of doxorubicin,
currently in Phase III development for the treatment of primary
liver cancer and in development for other cancer indications. The
Company’s product pipeline also includes GEN-1, a DNA-based
immunotherapy for the localized treatment of ovarian cancer.
Celsion has two platform technologies for the development of novel
nucleic acid-based immunotherapies and other anti-cancer DNA or RNA
therapies.
Forward-looking Statements
Forward-looking statements in this news release
are made pursuant to the "safe harbor" provisions of the Private
Securities Litigation Reform Act of 1995. Readers are cautioned
that such forward-looking statements involve risks and
uncertainties including, without limitation, unforeseen changes in
the course of research and development activities and in clinical
trials; the uncertainties of and difficulties in analyzing interim
clinical data, particularly in small subgroups that are not
statistically significant; FDA and regulatory uncertainties and
risks; the significant expense, time and risk of failure of
conducting clinical trials; the need for Celsion to evaluate its
future development plans; possible acquisitions or licenses of
other technologies, assets or businesses; possible actions by
customers, suppliers, competitors or regulatory authorities; and
other risks detailed from time to time in the Celsion's periodic
filings with the Securities and Exchange Commission. Celsion
assumes no obligation to update or supplement forward-looking
statements that become untrue because of subsequent events, new
information or otherwise.
Celsion Investor Contact
Jeffrey W. ChurchExecutive Vice President and
CFO609-482-2455jchurch@celsion.com
Or
LHA Investor RelationsKim
Sutton Golodetz212-838-3777kgolodetz@lhai.com
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